MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRODE

Model Number	DF59NC
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, we have been informed by our distributor (b)(6) about a malfunction with a defibrillation electrode at an unkown health care facility.The initial report specified: "i have received a complaint from one of our client regarding df59nc lot 210226-4019 which shows a problem on the cable." requesting further information on the malfunction we had been informed that no patient was harmed and that the customer detected two concerned defibnillation sets.No furher information has been made available on this malfunction despite repeated requests.
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually.All inspected samples were found to perform within limits.No faults were detected.We also received two photos showing the claimed cable defect.The product is packaged in a way that the cable is lead out of the pouch so the electrode set can be connected to a defibrillator well before its use.The pictures show detect that the defect on the section of the cable protruding from the pouch.The second detailed picture of the defect is very blurred.The defective area looks as if it had melted.The defect appears to be approx.1cm - 1.5cm in size.The involved devices have not been made available to the date of this report.However the customer has announced that the customer samples will be returned for a further investigation.Currently we are awaiting the samples for the investigation.After investigating them we can judge whether a reportable incident has occurred.We will provide a follow up report.This product is not marketed in the usa.No 510 (k) and no pma exist for it.However, devices made using a similar design are sold in the us.We are therefore reporting this malfunction as a precaution.
Event or Problem Description
On (b)(6) 2021, we have been informed by our distributor sarl immed europe, france, about a malfunction with a defibrillation electrode at an unkown health care facility.The initial report specified: "i have received a complaint from one of our client regarding df59nc lot 210226-4019 which shows a problem on the cable." requesting further information on the malfunction we had been informed that no patient was harmed and that the customer detected two concerned defibnillation sets.No furher information has been made available on this malfunction despite repeated requests.
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually.All inspected samples were found to perform within limits.No faults were detected.We also received two photos showing the claimed cable defect.The product is packaged in a way that the cable is lead out of the pouch so the electrode set can be connected to a defibrillator well before its use.The pictures show detect that the defect on the section of the cable protruding from the pouch.The second detailed picture of the defect is very blurred.The defective area looks as if it had melted.The defect appears to be approx.1cm - 1.5cm in size.We received two concerned customer sample pouches on (b)(6) 2022.As already mentioned by the distributor one electrode cable was already cut off from the pouch.A visual inspection of the two defibrilation set cables have shown a damaged insulation on both cables.Most likely caused by a high heat source.One cable set damage is so deep that cable strands are exposed.The production line was evaluated based on the returned customer samples.All stations on the production line were examined based on the defective cable.No possible cause can be determined.In addition, electrical continuity checks of the cable from the plug to the electrode rivet are carried out during the production process, which represents a possible detection of such a fault.In the entire defibrillation production process, no heat sources / seals or welding stations are used that can melt or burn a cable in such a way.Such a fault in the cable has never been detected before.Further on we have contacted our cable supplier for additional investigating this claimed failure.We have been informed that: "we had looked back to each process steps but cannot find potential cause for this specific defect.There is no electric heating tool/unit or exposed equipment heating part during the production of 92371 [the concerned cable].This also true to the whole assembly floor where the 92371 was produced.We also notice that the heat source could be pretty high according to the surface shrinking pattern and the black charcoal spot of the burned/melted area show in the picture.The defect area looks like is away from the injection forming area.Even for the forming failure, we will see pressed trace/mark which is smooth and more like mechanical force applied on soft plastic.Not like this burning mark." no root cause can be found what might have caused the claimed defect.Additionally we have contacted our distributor if the possibility may exist this failure was caused at the user facility.We have been informed that the user facility "no they received the goods like that".This product is not marketed in the usa.No 510 (k) and no pma exist for it.However, devices made using a similar design are sold in the us.We are therefore reporting this malfunction as a precaution.

• Brand Name: SKINTACT
• Common Device Name: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 13249285
• Report Number: 8020045-2022-00001
• Device Sequence Number: 20021876
• Product Code: MKJ
• UDI-Device Identifier: 19005531506449
• UDI-Public: (01)19005531506449
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: DF59NC
• Device Catalogue Number: DF59NC
• Device Lot Number: 210226-4019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown